MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Pain (1994); Weakness (2145); Treatment with medication(s) (2571)

Event Date 06/25/2014

Event Type  Injury  

Event Description

It was reported by the patient that they underwent a sling procedure on 06/25/2014 and mesh was implanted.Following the procedure, the patient began to experience pelvic groin and thigh pain.The patient switched insurance and could no longer go back to the hospital where the surgery was performed.The patient went to a urogynecologist who prescribed oxycontin but could not remove the mesh as the physician opined they had never used the mesh product.The patient continued to suffer from pain and weakness and collapsed on the floor.The patient then went to see a gynecologist who prescribed celiomycin for a reddened, painful vaginal area.The patient stated, "it feels like i'm sitting on a stick and burns like fire¿.Since the procedure, the patient is requesting that mesh be taken out and states that the doctors seen will not remove the mesh because they opined they have never used this type of mesh before.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: GYNECARE TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4749007
• MDR Text Key: 16545235
• Report Number: 2210968-2015-05256
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR